Thorough characterization of a Self-Emulsifying Drug Delivery System with Raman hyperspectral imaging: A case study

Abstract

Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their activity, among which, Self-Emulsifying Drug Delivery System (SEDDS).The efficacy of the drugs contained in these preparations is mainly affected by the solid state and the particle size of the active pharmaceutical ingredient (API).However, it is quite complex, long and expensive to characterize these parameters with classical techniques such as X-Ray powder diffraction, differential scanning calorimetry or hot stage microscopy.The present article presents, through a case study, the advantages of the Raman hyperspectral imaging in the characterization of such formulations. Indeed, Raman chemical imaging may fully characterize SEDDS with single equipment and operator in a non-destructive way allowing the follow-up of the formulation during stability studies. Raman imaging is therefore a tool of choice in the PAT framework since it increases the knowledge of the formulation and the process. 2A quantitative multivariate method using Raman hyperspectral imaging to assay the API in the lipid based formulation has been developed and fully validated following the "total error" approach.

Extraction of information about structural changes in a semisolid pharmaceutical formulation from near‐infrared and Raman images by multivariate curve resolution–alternating least squares and ComDim

“…This result is in accordance with the literature, where it is described that excipients typically have a higher signal in infrared spectra due to α‐bonding, whereas active principles often present higher Raman signals due to the presence of π‐electrons 46 . Due to this characteristic, Raman spectra are widely used in the characterization of API, as described above 36,47,48 . Also, Bhavana et al demonstrated that Raman was better than NIR and FTIR at differentiating three different solvated forms of niclosamide.…”

“…46 Due to this characteristic, Raman spectra are widely used in the characterization of API, as described above. 36,47,48 Also, Bhavana et al demonstrated that Raman was better than NIR and FTIR at differentiating three different solvated forms of niclosamide. Among the factors affecting this performance difference are the higher sensitivity of Raman spectroscopy to sample homogeneity and particle size uniformity.…”

Harnessing Birefringence for Real-Time Classification of Molecular Crystals Using Dynamic Polarized Light Microscopy, Microfluidics, and Machine Learning

“…Analytical techniques commonly employed for the characterization of molecular crystal forms, such as nuclear magnetic resonance (NMR), , XRD, ,,− Raman spectroscopy, , and infrared spectroscopy (IR) , require extensive sample preparation procedures for ensemble crystal form analysis. On the contrary, our method enables rapid classification of crystal forms at a single crystal level, through direct sampling of the crystal slurry via the slit-based flow cell and imaging of crystals with their interference colors.…”

Characterization of pharmaceutically relevant materials at the solid state employing chemometrics methods

“…A quantitative Raman-CI/PLS to assay the API in the lipid based formulation was also developed and fully validated following the "total error" approach. SNV and MC were employed as data pre-processing methods [72]. On the other hand, SIMCA and ANN were employed to classify polymers based on their thermo-mechanical properties [73].…”